ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy (HULPVAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01824069
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
Hospital Universitario La Paz
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Brief Summary:

It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula. With this project we will address a study population with critical ischemia of lower limbs without possibility of revascularization, either by technical criteria (no intervention possible to compensate for the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for the type of intervention required). It will almost always elderly patients with multiple comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with very high probability of major amputation in the short term or immediate.

Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded "ex vivo", are capable of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable a safe manner


Condition or disease Intervention/treatment Phase
Nonrevascularizable Critical Ischemia of the Lower Limbs Other: Intramuscular injection of a suspension of adult mesenchymal stem cells derived Phase 1 Phase 2

Detailed Description:

The primary endpoint of safety and feasibility study will be done when the patient has received treatment at 12 months after implantation. It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. All adverse events will be collected during the same time monitoring the clinical evaluation. The main objective will be assessed the cumulative incidence of adverse effects attributed to the study therapy.

Secondary endpoints: As part of the evaluation of the quality of life of patients and clinical evaluation of the treatment will be at 6, 9 and 12 months after implantation a Test SF-12, a magnetic resonance angiography, and tissue oximetry records ankle-brachial index


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIa Clinical Trial to Safety of Treatment in Critical Ischemia Nonrevascularizable Lower Limb by Mesenchymal Stem Cells
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Autologous mesenchymal stem cells
Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight in a dosis
Other: Intramuscular injection of a suspension of adult mesenchymal stem cells derived
Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight. Only one dosis by patients




Primary Outcome Measures :
  1. Safety of inject mesenchymal stem cells in MMII [ Time Frame: one year ]
    It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial.


Secondary Outcome Measures :
  1. Quality of life of patients after treatment [ Time Frame: one year ]
    We analyze the quality of life of patients by SF-12 test


Other Outcome Measures:
  1. Clinical evaluation of patients after treatment [ Time Frame: One year ]
    Clinical evaluation of patients after treatment with magnetic resonance angiography, tissue oximetry records and ankle-brachial index.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed Consent.
  2. > 18 years.
  3. Chronic arterial ischemia grades IV-V of Rutherford that affects at least one limb.
  4. Arterial occlusion direct flow or distal femoropopliteal level.
  5. No option for surgical or endovascular revascularization.
  6. Life expectancy exceeding two years.
  7. High probability of need for major amputation at 6 months (CLI nonrevascularizable).
  8. Negative pregnancy test if applicable.

Exclusion Criteria:

  1. Background of hematologic neoplasia or unresolved.
  2. Hipertensión uncontrolled blood (> 180/110).
  3. Severe heart Insuficiencia (New York Heart Association [NYHA] IV) or ejection fraction <30%.
  4. Malignant ventricular, Arritmias.
  5. Trombosis of deep vein the past three months.
  6. active infection.
  7. Infarto infarction or stroke the previous three months.
  8. Medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
  9. Subjects with congenital or acquired immunodeficiencies. Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion, treponema.
  10. Major surgery or severe trauma of the subject in the previous semester.
  11. Administration of any investigational drug at present to three months prior to enrollment for this trial.
  12. Pulmonary heart disease, in the opinion of the investigator, be unstable or is sufficiently serious to dismiss the patient from the study.
  13. Infants or pregnant women.
  14. Adult women of childbearing potential not using effective contraception during the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824069


Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Hospital Universitario La Paz
Investigators
Principal Investigator: Luis Riera del Moral, Doctor Instituto de Investigación Hospital Universitario La Paz

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01824069     History of Changes
Other Study ID Numbers: HULPVAS-2011-01
2012-000290-23 ( EudraCT Number )
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: April 2013

Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Critical Ischemia
Amputation

Additional relevant MeSH terms:
Ischemia
Pathologic Processes